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Med-Hot Thermal Imaging, Inc. recalls MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use a
Recalled May 17, 2017 · FDA recall Z-2057-2017 · Med-Hot Thermal Imaging
Hazard
Indications for use are not cleared or approved for market in the U.S. · FDA Class II
Units
12
Sold at
US: AL and NJ - Foreign: Nigeria
Description
Indications for use are not cleared or approved for market in the U.S.
Product
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.
Manufacturer(s)
Med-Hot Thermal Imaging, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →